Optimizing Cortical Priming
Optimizing Cortical Priming to Enhance Bimanual Arm Coordination in Individuals With Chronic Stroke
Each year over 795,000 people suffer from stroke resulting in the primary cause of adult disability. Persistent upper limb dysfunction due to stroke significantly impairs performance and results in a serious decline of quality of life. As most daily activities involve the use of both arms, restoring the coordination between upper limbs is essential for regaining functional independence. Only a few interventions have been designed for improving function of both arms, and most of these interventions have focused on movement retraining without directly facilitating the injured brain. The purpose of this study is to design and test a noninvasive brain stimulation protocol tailored to enhance the coordination between the arms in individuals with chronic stroke. The investigators propose that the dorsal premotor cortex on the noninjured side of the brain (cPMd) could serve as a potential stimulation target for enhancing arm coordination and brain function. In the first part of this study (Aim 1), the investigators will examine its effects on modulating arm movements in individuals with chronic stroke. In the second part of this study (Aim 2), the investigators will upregulate the activity of the most responsive region (cPMd or iM1) of each participant prior to arm movement training (bilateral arm training, BAT) to determine the combined effects on augmenting bilateral arm coordination and brain function in individuals with chronic stroke.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna
- Physical Therapy & Rehabilitation Science, University of Maryland Baltimore
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Stroke Participants:
- Age 50 years and older
- Unilateral ischemic cortical or white matter subcortical stroke
- At least 6 months post-stroke and have completed all inpatient and outpatient therapy
- Residual arm paresis as indicated by Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores between 25 and 65 (individuals in this range have demonstrated the ability to generate motor evoked potentials during active muscle contraction)
- Able to reach forward for at least 15 centimeters
Healthy Controls:
- Age-matched to a stroke participant within plus or minus 3 years
- Gender-matched to a stroke participant
Exclusion Criteria:
Stroke Participants and Healthy Controls:
- A non-stroke neuromuscular disorder restricting exercise
- Stroke involving the brainstem or cerebellum
- Any medical conditions that could limit physical activity levels required for testing and training, such as acute cardiac or pulmonary/respiratory conditions, or uncontrolled hypertension (blood pressure greater than 180/100 mmHg)
- Significant orthopedic or chronic pain conditions limiting upper extremity movements
- Any medications that may adversely impact upper extremity control
- Metallic implant in the head or chest, implanted pumps/stimulators/shunts, or cardiac pacemaker
- A history of seizures
- Use of any neuropsychoactive medication
- History of fainting spells of undetermined etiology
- Pregnancy
- Any other concomitant neurological condition affecting sensorimotor systems, such as brain tumor, substance abuse, or dementia
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 5 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) over Contralesional Dorsal Premotor Cortex
Participants received high-frequency (5 Hz) repetitive Transcranial Magnetic Stimulation (rTMS) delivered over the contralesional dorsal premotor cortex (cPMd) using a figure-of-eight magnetic coil. In Aim 1, participants received a single session of 5 Hz cPMd rTMS only. In Aim 2, participants who were responsive to cPMd stimulation received 5 Hz cPMd rTMS immediately prior to bilateral arm training (BAT) for 3 sessions. |
Participant received 5 Hz repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd) only (Aim 1) and 5 Hz repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd) combined with 3 essions of bilateral arm training (Aim 2) |
|
Experimentell: 5 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) over Ipsilesional Primary Motor Cortex
Participants received high-frequency (5 Hz) repetitive Transcranial Magnetic Stimulation (rTMS) delivered over the ipsilesional primary motor cortex (iM1) using a figure-of-eight magnetic coil. In Aim 1, participants received a single session of iM1 rTMS only. In Aim 2, participants who were responsive to iM1 stimulation received iM1 rTMS immediately prior to bilateral arm training (BAT) for 3 sessions. |
Participant received 5 Hz rTMS on the ipsilesional primary motor cortex (iM1) only (Aim 1) and 5 Hz rTMS on the ipsilesional primary motor cortex (iM1) combined with 3 essions of bilateral arm training (Aim 2) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cortical Excitability Assessed by Transcranial Magnetic Stimulation (TMS)-Induced Motor Evoked Potential (MEP) Amplitude
Tidsram: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)
|
Cortical excitability was quantified using single-pulse Transcranial Magnetic Stimulation (TMS) over the targeted motor cortex. Peak-to-peak amplitude of Motor Evoked Potentials (MEPs) recorded from the target upper limb muscle via surface electromyography (EMG) was measured in microvolts to evaluate stimulation- and training-induced neuroplastic changes. |
Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)
|
|
Interlimb Coordination Assessed by Surface Electromyography (EMG) -Interlimb Muscle Coherence
Tidsram: Day 1: Baseline and within 30 minutes post-stimulation (Aim 1)
|
Interlimb coordination was quantified by measuring interlimb muscle coherence (intermuscular coherence) between homologous upper limb muscles via surface electromyography (EMG) during bilateral arm movements. Coherence was calculated in the frequency domain, where higher values indicated greater synchronous neural drive and coordination between the two upper limbs. |
Day 1: Baseline and within 30 minutes post-stimulation (Aim 1)
|
|
Arm Reaching Kinematics (Speed, Acceleration, Interlimb Coordination, and Trajectory Smoothness) Assessed by the 3D Kinesiological Instrument for Normal and Altered Reaching Movement (KINARM)
Tidsram: Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training) (Aim 2)
|
Upper limb kinematic performance during arm reaching tasks was assessed using the 3D Kinesiological Instrument (KINARM). Specific kinematic parameters analyzed included: (1) movement speed, (2) movement acceleration, (3) interlimb coordination, and (4) arm trajectory smoothness. |
Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training) (Aim 2)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intracortical Inhibition Assessed by Paired-Pulse Transcranial Magnetic Stimulation (TMS)- Short-Interval Intracortical Inhibition (SICI)
Tidsram: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)
|
Intracortical inhibition was quantified using paired-pulse Transcranial Magnetic Stimulation (TMS) over the motor cortex, recorded via surface electromyography (EMG) from the target upper limb muscle. A subthreshold conditioning stimulus followed by a suprathreshold test stimulus was applied. Intracortical inhibition was expressed as the ratio or percentage of the conditioned Motor Evoked Potential (MEP) amplitude relative to the unconditioned test MEP amplitude (% of test MEP), where lower percentages indicated greater intracortical inhibition. |
Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)
|
|
Interhemispheric Inhibition Assessed by Transcranial Magnetic Stimulation (TMS) Ipsilateral Silent Period (iSP)
Tidsram: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)
|
Interhemispheric inhibition was quantified by the Ipsilateral Silent Period (iSP), elicited by delivering single-pulse Transcranial Magnetic Stimulation (TMS) to the motor cortex ipsilateral to the target upper limb during voluntary isometric muscle contraction. The iSP was recorded via surface electromyography (EMG) and quantified by duration in milliseconds (ms) and normalized area of EMG suppression (%). |
Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)
|
|
Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)
Tidsram: Aim 1: Day 1 (Baseline); Aim 2: Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training)
|
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a performance-based impairment index used to assess upper limb motor recovery in individuals with post-stroke hemiparesis. The upper extremity motor domain consists of 33 items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), yielding a total motor score ranging from 0 to 66, where higher scores indicate better upper extremity motor function (less motor impairment). |
Aim 1: Day 1 (Baseline); Aim 2: Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HP00068268
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
To protect the privacy of stroke participants and adhere to the Institutional Review Board (IRB) guidelines, individual participant data (IPD) will not be made publicly available. The raw neurophysiological data and clinical assessments are reserved for the research team to complete the primary and secondary analyses specified in the study protocol. However, de-identified aggregate results and study documents will be shared through peer-reviewed publications. Some participant data were shared on one of our publications (https://doi.org/10.1016/j.clinph.2019.04.711)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .